Plot twist for negative FAME 3 results: early QoL benefits of PCI

The FAME 3 trial previously failed to meet its criteria for non-inferiority comparing percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) with coronary artery bypass grafting (CABG) for treating 3-vessel coronary artery disease. A new subanalysis suggests that PCI may be associated with early improvements in quality of life; however, results did not extend out to 1 year.

The full FAME 3 study (NCT02100722), published recently in the New England Journal of Medicine, reported that in patients with 3-vessel coronary artery disease, FFR-guided PCI (n=757) was not better than CABG (n=743) with respect to the incidence of a composite of death, myocardial infarction, stroke, or repeat revascularisation at 1 year [1]. At the ACC 2022, Dr Frederik Zimmermann (Catharina Hospital, the Netherlands) presented the results of a QoL subanalysis, which was simultaneously published in Circulation [2,3].

The FAME 3 study participants filled in the European Quality of Life–5 Dimensions (EQ-5D) and its associated visual analogue scale at the beginning of the trial, and at months 1 and 12 of follow-up. The EQ-5D QoL scores were improved for PCI compared with CABG for the first 2 time points, but were lost at 12 months: at baseline, 0.827 versus 0.821 (P<0.001); 1 month, 0.891 versus 0.830 (P<0.001); 12 months, 0.874 versus 0.873 (P=0.95). Likewise, the incidence of angina, as assessed by ≥2 grade of the Canadian Cardiovascular Society angina score, showed no difference at 12 months: 6.2% versus 3.1% (P>0.05). At 1 year, more participants regained functional status with PCI than with CABG, as measured by the return to work in patients <65 years: 68% versus 57% (P<0.05).

Collectively, the QoL data from FAME 3 do support early effects of PCI over CABG for QoL, but this effect diminished after 12 months post-procedure. A higher return to work rate was observed after 1 year in the FFR-guided PCI group. This data should be considered when shared-decision making with your patient is indicated.

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   1. Fearon WF, et al. N Engl J Med 2022;386(2):128–137.
   2. Zimmermann F, et al. Quality Of Life After Fractional Flow Reserve-guided Stenting Compared With Coronary Bypass Surgery: The Fame 3 Trial. Abstract 403-14, ACC 2022, 2–4 April, Washington DC, USA.
   3. Fearon WF, et al. Circulation. 2022;145:1655–1662.

 

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Posted on 15 June 202223 April 2024